Effect of Alirocumab on Lipoprotein(a) Over ≥1.5 Years (from the Phase 3 ODYSSEY Program).
Identifieur interne : 000D61 ( Main/Exploration ); précédent : 000D60; suivant : 000D62Effect of Alirocumab on Lipoprotein(a) Over ≥1.5 Years (from the Phase 3 ODYSSEY Program).
Auteurs : Daniel Gaudet [Canada] ; Gerald F. Watts [Australie] ; Jennifer G. Robinson [États-Unis] ; Pascal Minini [France] ; William J. Sasiela [États-Unis] ; Jay Edelberg [États-Unis] ; Michael J. Louie [États-Unis] ; Frederick J. Raal [Afrique du Sud]Source :
- The American journal of cardiology [ 1879-1913 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Anticholestérolémiants (usage thérapeutique), Anticorps monoclonaux (usage thérapeutique), Association de médicaments, Détermination du point final, Femelle, Humains, Hypercholestérolémie (traitement médicamenteux), Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase (usage thérapeutique), Lipoprotéine (a) (), Mâle, Méthode en double aveugle, Résultat thérapeutique, Ézétimibe.
- MESH :
- traitement médicamenteux : Hypercholestérolémie.
- usage thérapeutique : Anticholestérolémiants, Anticorps monoclonaux, Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase.
- Adulte d'âge moyen, Association de médicaments, Détermination du point final, Femelle, Humains, Lipoprotéine (a), Mâle, Méthode en double aveugle, Résultat thérapeutique, Ézétimibe.
English descriptors
- KwdEn :
- Antibodies, Monoclonal (therapeutic use), Anticholesteremic Agents (therapeutic use), Double-Blind Method, Drug Therapy, Combination, Endpoint Determination, Ezetimibe, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use), Hypercholesterolemia (drug therapy), Lipoprotein(a) (drug effects), Male, Middle Aged, Treatment Outcome.
- MESH :
- chemical , drug effects : Lipoprotein(a).
- chemical , therapeutic use : Antibodies, Monoclonal, Anticholesteremic Agents, Hydroxymethylglutaryl-CoA Reductase Inhibitors.
- drug therapy : Hypercholesterolemia.
- Double-Blind Method, Drug Therapy, Combination, Endpoint Determination, Ezetimibe, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
Elevated lipoprotein(a) [Lp(a)] is independently associated with increased cardiovascular risk. However, treatment options for elevated Lp(a) are limited. Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, reduced low-density lipoprotein cholesterol (LDL-C) by up to 62% from baseline in phase 3 studies, with adverse event rates similar between alirocumab and controls. We evaluated the effect of alirocumab on serum Lp(a) using pooled data from the phase 3 ODYSSEY program: 4,915 patients with hypercholesterolemia from 10 phase 3 studies were included. Eight studies evaluated alirocumab 75 mg every 2 weeks (Q2W), with possible increase to 150 mg Q2W at week 12 depending on LDL-C at week 8 (75/150 mg Q2W); the other 2 studies evaluated alirocumab 150-mg Q2W from the outset. Comparators were placebo or ezetimibe. Eight studies were conducted on a background of statins, and 2 studies were carried out with no statins. Alirocumab was associated with significant reductions in Lp(a), regardless of starting dose and use of concomitant statins. At week 24, reductions from baseline were 23% to 27% with alirocumab 75/150-mg Q2W and 29% with alirocumab 150-mg Q2W (all comparisons p <0.0001 vs controls). Reductions were sustained over 78 to 104 weeks. Lp(a) reductions with alirocumab were independent of race, gender, presence of familial hypercholesterolemia, baseline Lp(a), and LDL-C concentrations, or use of statins. In conclusion, in addition to marked reduction in LDL-C, alirocumab leads to a significant and sustained lowering of Lp(a).
DOI: 10.1016/j.amjcard.2016.09.010
PubMed: 27793396
Affiliations:
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Electronic address: daniel.gaudet@umontreal.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, ECOGENE-21 Clinical and Translational Research Center and Lipidology Unit, Université de Montréal, Chicoutimi, Quebec</wicri:regionArea><wicri:noRegion>Quebec</wicri:noRegion></affiliation></author><author><name sortKey="Watts, Gerald F" sort="Watts, Gerald F" uniqKey="Watts G" first="Gerald F" last="Watts">Gerald F. Watts</name><affiliation wicri:level="1"><nlm:affiliation>Lipid Disorders Clinic, Centre for Cardiovascular Medicine, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Lipid Disorders Clinic, Centre for Cardiovascular Medicine, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia</wicri:regionArea><wicri:noRegion>Western Australia</wicri:noRegion></affiliation></author><author><name sortKey="Robinson, Jennifer G" sort="Robinson, Jennifer G" uniqKey="Robinson J" first="Jennifer G" last="Robinson">Jennifer G. Robinson</name><affiliation wicri:level="2"><nlm:affiliation>University of Iowa, Iowa City, Iowa.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Iowa</region></placeName><wicri:cityArea>University of Iowa, Iowa City</wicri:cityArea></affiliation></author><author><name sortKey="Minini, Pascal" sort="Minini, Pascal" uniqKey="Minini P" first="Pascal" last="Minini">Pascal Minini</name><affiliation wicri:level="1"><nlm:affiliation>Biostatistics and Programming, Sanofi, Chilly-Mazarin, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Biostatistics and Programming, Sanofi, Chilly-Mazarin</wicri:regionArea><wicri:noRegion>Chilly-Mazarin</wicri:noRegion><wicri:noRegion>Chilly-Mazarin</wicri:noRegion></affiliation></author><author><name sortKey="Sasiela, William J" sort="Sasiela, William J" uniqKey="Sasiela W" first="William J" last="Sasiela">William J. Sasiela</name><affiliation wicri:level="2"><nlm:affiliation>Regeneron Pharmaceuticals, Inc., Tarrytown, New York.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Regeneron Pharmaceuticals, Inc., Tarrytown</wicri:cityArea></affiliation></author><author><name sortKey="Edelberg, Jay" sort="Edelberg, Jay" uniqKey="Edelberg J" first="Jay" last="Edelberg">Jay Edelberg</name><affiliation wicri:level="2"><nlm:affiliation>Sanofi, Bridgewater, New Jersey.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Sanofi, Bridgewater</wicri:cityArea></affiliation></author><author><name sortKey="Louie, Michael J" sort="Louie, Michael J" uniqKey="Louie M" first="Michael J" last="Louie">Michael J. Louie</name><affiliation wicri:level="2"><nlm:affiliation>Regeneron Pharmaceuticals, Inc., Tarrytown, New York.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Regeneron Pharmaceuticals, Inc., Tarrytown</wicri:cityArea></affiliation></author><author><name sortKey="Raal, Frederick J" sort="Raal, Frederick J" uniqKey="Raal F" first="Frederick J" last="Raal">Frederick J. Raal</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Faculty of Health Sciences, University of Witwatersrand, Johannesburg</wicri:regionArea><wicri:noRegion>Johannesburg</wicri:noRegion></affiliation></author></analytic><series><title level="j">The American journal of cardiology</title><idno type="eISSN">1879-1913</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antibodies, Monoclonal (therapeutic use)</term><term>Anticholesteremic Agents (therapeutic use)</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Endpoint Determination</term><term>Ezetimibe</term><term>Female</term><term>Humans</term><term>Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)</term><term>Hypercholesterolemia (drug therapy)</term><term>Lipoprotein(a) (drug effects)</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Anticholestérolémiants (usage thérapeutique)</term><term>Anticorps monoclonaux (usage thérapeutique)</term><term>Association de médicaments</term><term>Détermination du point final</term><term>Femelle</term><term>Humains</term><term>Hypercholestérolémie (traitement médicamenteux)</term><term>Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase (usage thérapeutique)</term><term>Lipoprotéine (a) ()</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Ézétimibe</term></keywords><keywords scheme="MESH" type="chemical" qualifier="drug effects" xml:lang="en"><term>Lipoprotein(a)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Anticholesteremic Agents</term><term>Hydroxymethylglutaryl-CoA Reductase Inhibitors</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hypercholesterolemia</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Hypercholestérolémie</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticholestérolémiants</term><term>Anticorps monoclonaux</term><term>Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Endpoint Determination</term><term>Ezetimibe</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Association de médicaments</term><term>Détermination du point final</term><term>Femelle</term><term>Humains</term><term>Lipoprotéine (a)</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Ézétimibe</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Elevated lipoprotein(a) [Lp(a)] is independently associated with increased cardiovascular risk. However, treatment options for elevated Lp(a) are limited. Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, reduced low-density lipoprotein cholesterol (LDL-C) by up to 62% from baseline in phase 3 studies, with adverse event rates similar between alirocumab and controls. We evaluated the effect of alirocumab on serum Lp(a) using pooled data from the phase 3 ODYSSEY program: 4,915 patients with hypercholesterolemia from 10 phase 3 studies were included. Eight studies evaluated alirocumab 75 mg every 2 weeks (Q2W), with possible increase to 150 mg Q2W at week 12 depending on LDL-C at week 8 (75/150 mg Q2W); the other 2 studies evaluated alirocumab 150-mg Q2W from the outset. Comparators were placebo or ezetimibe. Eight studies were conducted on a background of statins, and 2 studies were carried out with no statins. Alirocumab was associated with significant reductions in Lp(a), regardless of starting dose and use of concomitant statins. At week 24, reductions from baseline were 23% to 27% with alirocumab 75/150-mg Q2W and 29% with alirocumab 150-mg Q2W (all comparisons p <0.0001 vs controls). Reductions were sustained over 78 to 104 weeks. Lp(a) reductions with alirocumab were independent of race, gender, presence of familial hypercholesterolemia, baseline Lp(a), and LDL-C concentrations, or use of statins. In conclusion, in addition to marked reduction in LDL-C, alirocumab leads to a significant and sustained lowering of Lp(a).</div></front></TEI><affiliations><list><country><li>Afrique du Sud</li><li>Australie</li><li>Canada</li><li>France</li><li>États-Unis</li></country><region><li>Iowa</li><li>New Jersey</li><li>État de New York</li></region></list><tree><country name="Canada"><noRegion><name sortKey="Gaudet, Daniel" sort="Gaudet, Daniel" uniqKey="Gaudet D" first="Daniel" last="Gaudet">Daniel Gaudet</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Watts, Gerald F" sort="Watts, Gerald F" uniqKey="Watts G" first="Gerald F" last="Watts">Gerald F. Watts</name></noRegion></country><country name="États-Unis"><region name="Iowa"><name sortKey="Robinson, Jennifer G" sort="Robinson, Jennifer G" uniqKey="Robinson J" first="Jennifer G" last="Robinson">Jennifer G. Robinson</name></region><name sortKey="Edelberg, Jay" sort="Edelberg, Jay" uniqKey="Edelberg J" first="Jay" last="Edelberg">Jay Edelberg</name><name sortKey="Louie, Michael J" sort="Louie, Michael J" uniqKey="Louie M" first="Michael J" last="Louie">Michael J. Louie</name><name sortKey="Sasiela, William J" sort="Sasiela, William J" uniqKey="Sasiela W" first="William J" last="Sasiela">William J. Sasiela</name></country><country name="France"><noRegion><name sortKey="Minini, Pascal" sort="Minini, Pascal" uniqKey="Minini P" first="Pascal" last="Minini">Pascal Minini</name></noRegion></country><country name="Afrique du Sud"><noRegion><name sortKey="Raal, Frederick J" sort="Raal, Frederick J" uniqKey="Raal F" first="Frederick J" last="Raal">Frederick J. Raal</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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